Selective aortic balloon occlusion device, methods of use, and uses thereof

ABSTRACT

A selective aortic balloon device includes a catheter comprising an open distal end configured to be inserted into a body cavity or vessel, and a plurality of adjustable port regions with inflatable balloons between adjacent adjustable port regions. Each adjustable port region is configured to move between a closed position and an open position to selectively allow fluid flow to enter the catheter through the open distal end and to exit the catheter through one or more of the plurality of adjustable port regions depending on an inflation pattern of the inflatable balloons.

CROSS-REFERENCE TO RELATED APPLICATION

This application is related to co-pending application Ser. No.14/830,342 entitled “NARROW PROFILE BALLOON FOR USE WITH AN OCCLUSIONDEVICE, METHODS OF USE, AND USES THEREOF” which is incorporated hereinby reference in its entirety.

TECHNICAL FIELD

The disclosure herein relates in general to aortic balloon occlusiondevices, and in particular, to selective, resuscitative aortic balloonocclusion devices, methods of use, and uses thereof.

BACKGROUND

Conventional afterload enhancement devices include, as examples, theMAST, introduced in 1903, the aortic cross clamp, and the resuscitativeendovascular balloon occlusion of the aorta. Each of these devices hasdrawbacks that limit their effectiveness and uses. As non-limitingexamples, the current technology offers an all-or-nothing approach tointra-abdominal bleeding, poor control over reperfusion, no ability tomaintain renal and distal perfusion with intra-abdominal bleeding,difficult precise placement of the balloon or balloons, and a crudeestimation of pressure applied to vasculature that can result in aorticrupture.

SUMMARY

Disclosed herein is a narrow profile balloon for use with a catheterthat allows for precise placement of the balloon and accurate estimationof the pressure applied to the vasculature, along with other advantagesdescribed herein.

One embodiment of a narrow profile balloon for use with a catheter asdisclosed herein comprises an anchored end fixed to the catheter, amovable end distal to the fixed end, a wall extending between theanchored end and the movable end, an inflatable tube located along thewall and circumscribing the wall, and at least one tension wire attachedto the movable end and extending through the catheter such that the atleast one tension wire is accessible to move the movable end of theballoon towards the anchored end when the catheter is positioned in abody cavity.

Disclosed herein are embodiments of an aortic occlusion device. Oneembodiment of an aortic occlusion device comprises a catheter and aballoon mounted along the catheter, wherein the balloon is a narrowprofile balloon. The narrow profile balloon comprises an anchored endfixed to the catheter, a movable end distal to the fixed end, a wallextending between the anchored end and the movable end, an inflatabletube located proximate along the wall and circumscribing the wall, andat least one tension wire attached to the movable end and extendingthrough the catheter such that the at least one tension wire isaccessible to move the movable end of the balloon towards the anchoredend when the catheter is positioned in the aorta.

Also disclosed herein are methods of using the narrow profile balloonand the aortic occlusion device. One such method of using the aorticocclusion device, where the aortic occlusion device has a plurality ofballoons, at least one of the plurality of balloons being the narrowprofile balloon, comprises inserting the catheter into a body cavity orvessel within a human or animal body, positioning the catheter such thata distal balloon of the plurality of balloons is located proximate adiaphragm, selectively inflating the inflatable tube of the narrowprofile balloon, and placing tension on the at least one tension wireattached to the movable end of the narrow profile balloon to move themovable end towards the anchored end, thereby moving the inflated tubeto contact a wall of the aorta, blocking blood flow below the inflatedtube.

Uses of the narrow profile balloon and the aortic occlusion device arealso disclosed herein.

Also disclosed herein are selective aortic balloon occlusion devices.One embodiment of a selective aortic balloon device comprises a cathetercomprising an open distal end and a plurality of adjustable port regionswith inflatable balloons between adjacent adjustable port regions. Eachadjustable port region is configured to move between a closed positionand an open position to selectively allow fluid flow to enter thecatheter through the open distal end and to exit the catheter throughone or more of the plurality of adjustable port regions depending on apattern of one or more inflated balloons.

Another embodiment of a selective aortic balloon device comprises acatheter comprising a distal end configured to be inserted into a bodycavity or vessel, the distal end having at least one opening, a firstballoon downstream of the open distal end, a first adjustable portregion downstream of the first balloon, and a second balloon downstreamof the first adjustable port region and upstream of a closed proximateend. The first adjustable port region is configured to move between anopen position and a closed position, wherein the open position allowsflow into the distal end through the catheter and exiting through thefirst adjustable port region and the closed position prevents flowthrough the first adjustable port region.

In the embodiments of selective aortic balloon devices, the firstadjustable port region can comprise an outer catheter tube having atleast one outer aperture through an outer catheter tube wall, an innertube sized to movably fit within the outer catheter tube and having atleast one inner aperture through an inner tube wall, and a biasingmember attached to the inner tube, biasing the inner tube so that the atleast one inner aperture and the at least one outer aperture are offsetin the closed position. The biasing member is configured to move theinner tube to gradually overlap the at least one inner aperture and theat least one outer aperture through intermediate positions to the openposition, where the at least one inner aperture and the at least oneouter aperture are fully aligned.

In the embodiments of selective aortic balloon devices, the device canfurther comprise a second adjustable port region downstream of thesecond balloon and a third balloon downstream of the second adjustableport region, wherein the second adjustable port region is configured tomove between an open position and a closed position.

In the embodiments of selective aortic balloon devices, the device canfurther comprise a third adjustable port region downstream of the thirdballoon and upstream of a closed proximate end, wherein the thirdadjustable port region is configured to move between an open positionand a closed position.

Also disclosed are methods of using the selective aortic balloon devicesdisclosed herein. One method includes selectively inflating at least thefirst balloon and maintaining or moving with the external controller thefirst adjustable port region to the closed position to stop blood flowdownstream of the inflated first balloon. The method can also includeinflating the second balloon and maintaining or moving with the externalcontroller the first adjustable port region to the open position,thereby stopping blood flow downstream of the inflated second balloonwhile allowing blood to flow through the first adjustable port region.

Another method of using the selective aortic balloon occlusion devicesincludes inflating the third balloon, maintaining or moving the firstadjustable port region to the open position, and maintaining or movingthe second adjustable port region to the open position, thereby stoppingblood flow downstream of the inflated third balloon while allowing bloodto flow through the catheter through the distal end and out through thefirst adjustable port region and the second adjustable port region.

Another method of using the selective aortic balloon occlusion devicesincludes inflating one or both of the first balloon and the secondballoon, maintaining or moving the first adjustable port region to theclosed position, and maintaining or moving the second adjustable portregion to the open position, thereby stopping blood flow downstream ofthe inflated second balloon while allowing blood to flow through thecatheter into the distal end and out through the second adjustable portregion.

Another method of using the selective aortic balloon occlusion devicesincludes inflating the second balloon and the third balloon, maintainingor moving the first and third adjustable port regions to the openposition, and maintaining or moving the second adjustable port region tothe closed position, thereby preventing blood flow through the secondadjustable port region while allowing blood flow through the firstadjustable port region and the third adjustable port region.

Another method of using the selective aortic balloon occlusion devicesincludes inflating the third balloon, maintaining or moving the firstadjustable port region and the second adjustable region to the closedposition, and maintaining or moving the third adjustable port region tothe closed position, thereby bypassing blood flow through the catheterto exit through the third adjustable port region.

Another method of using the selective aortic balloon occlusion devicesincludes inflating the third balloon, maintaining or moving the firstadjustable port region to the open position, maintaining or moving thethird adjustable port region to the closed position, and maintaining ormoving the second adjustable port region to the open position, therebyproviding blood flow through the catheter to exit through the first andsecond adjustable port regions while preventing blood flow through thethird adjustable port region.

Variations in these and other aspects, features, elements,implementations, and embodiments of the methods, apparatus, procedures,and algorithms disclosed herein are described in further detailhereafter.

BRIEF DESCRIPTION OF THE DRAWINGS

The various aspects of the methods and apparatuses disclosed herein willbecome more apparent by referring to the examples provided in thefollowing description and drawings in which:

FIG. 1 is a perspective view of a narrow profile balloon on a catheter;

FIG. 2 is a perspective view of the narrow profile balloon of FIG. 1 ina partially contracted state on a catheter;

FIG. 3 is a perspective view of the narrow profile balloon of FIG. 1 ina fully contracted state on a catheter;

FIG. 4 is a perspective view of the narrow profile balloon of FIG. 2with the catheter and tension wires shown in broken line;

FIG. 5 is a side view of a catheter having three narrow profile balloonsillustrating placement of the narrow profile balloons along a descendingaorta;

FIG. 6 is an illustration of the descending aorta in a human body;

FIG. 7A is an illustration of the catheter of FIG. 5 in the descendingaorta with all three of the narrow profile balloons in a fullycontracted position;

FIG. 7B is an illustration of the catheter of FIG. 5 in the descendingaorta with one of the narrow profile balloons extending along thecatheter and two of the narrow profile balloons in a fully contractedposition;

FIG. 8 is a perspective view of an external controller for the narrowprofile balloons;

FIG. 9 is a flow diagram of a method of using the catheter with narrowprofile balloons;

FIG. 10 is a side view of an embodiment of a selective aortic balloonocclusion device;

FIG. 11 is an enlarged view of an adjustable port region of theselective aortic balloon occlusion device of FIG. 10;

FIGS. 12A-12C are enlarged views of the adjustable port region of FIG.11 illustrating the progression between a closed position and an openposition;

FIG. 13 is a perspective view of an external controller for the narrowprofile balloons and the adjustable port regions;

FIG. 14 is a side view of another embodiment of a selective aorticballoon occlusion device;

FIG. 15 is a flow diagram of a method of using the selective aorticballoon occlusion device of FIG. 14;

FIG. 16 is an illustration of the selective aortic balloon occlusiondevice of FIG. 15 in the descending aorta;

FIG. 17 is a flow diagram of a method of using the selective aorticballoon occlusion device of FIG. 10; and

FIG. 18 is a side view of the selective aortic balloon occlusion deviceof FIG. 10 illustrating placement of the device along a descendingaorta.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Disclosed herein is a narrow profile balloon illustrated in FIGS. 1-4for use on a catheter which is placed in a body cavity of a human or ananimal. This device enables the deployment of the narrow profile balloonfor use within cavities with limited space, such as blood vessels. Thenarrow profile balloon allows for precise placement between vesselsunlike any conventional balloons. For example, the narrow profileballoon can be precisely placed in the aorta between the renal trunk andthe celiac trunk, without blocking either trunk directly. Conventionalballoons have longitudinally extended walls that are expanded andcontact a longitudinally extended area of the cavity such as a vessel.This longitudinal wall of the balloon makes it difficult to preciselyposition the balloon between closely spaced trunks without blocking oneor both of the trunks.

The narrow profile balloon as used herein refers to a flexible tube aswell as the mounting frame structure of the flexible tube. The flexibletube can be inflatable with fluid such as air, or can be a soft seal ofa material such as rubber, mounted on a contractible and expandableframe. The frame is permanently attached at its proximal end and ismobile at its distal end. The distal end is attached to tension cords,which allow the user to expand the device in order to safely occlude avessel, as a non-limiting example.

As shown in FIGS. 1-3, a narrow profile balloon 10 for use with acatheter 12 comprises an anchored end 14 fixed to the catheter 12, amovable end 16 distal to the fixed end 14, a wall 18 extending betweenthe anchored end 14 and the movable end 16, a flexible tube 20 locatedalong the wall 18 and circumscribing the wall 18, and at least onetension wire 22 attached to the movable end 16 and extending through thecatheter 12 such that an end of the at least one tension wire 22 isaccessible outside of the catheter 12. When the at least one tensionwire 22 is tensioned by a user, the movable end 16 of the balloon 10moves toward the anchored end 14, thereby moving the flexible tube 20toward a wall of a body cavity in which the catheter 12 is positioned.

The flexible tube 20 is mounted on a frame that includes the wall 18,the movable end 16 and the anchored end 14. The wall 18 can be made of amaterial such as rubber or a flexible plastic. The frame can includesupport 24 such as semi-stiff wires which can be embedded in thematerial of the wall 18 or can be internal to the material of the wall18 to maintain the shape of the wall 18 as the balloon 10 is tensioned.The support 24 can be a metal, plastic, resin, ceramic or fibermaterials, as non-limiting examples, that have sufficient rigidity tomaintain the shape of the wall 18. The support 24 can extend the lengthof the wall 18 with a portion aligned with the flexible tube 20 thatbends, or the support 24 can extend along the wall 18 from the flexibletube 20 to each of the movable end 16 and the anchored end 14. Theanchored end 14 and the movable end 16 can be non-flexible rings ofmaterial embedded in opposing ends of the wall 18. The flexible tube 20can be positioned as shown, along a longitudinal center X of the wall 18as a non-limiting example. The flexible tube 20 circumscribes theexterior of the wall 18 so that when the narrow profile balloon 10 istensioned, the flexible tube 20 is the only portion of the narrowprofile balloon 10 that contacts a wall of the cavity in which thecatheter 12 is inserted. As used herein, “cavity” can mean organ,artery, vein, or other internal body cavity in which the narrow profileballoon can be used for any purpose.

When the catheter 12 is inserted into a body cavity, the narrow profileballoon 10 is extended to its full length, as shown in FIG. 1, with noor insufficient tension on the tension wire 22 to move the movable end16 toward the anchored end 14. Once the catheter 12 is placed in thebody cavity, the at least one tension wire 22 is pulled with the endexternal to the catheter 12 and body to move the movable end 16 towardthe anchored end 14, as shown in FIG. 2. The wall 18 is configured tofold at the flexible tube 20 when tension is placed on the tension wire22. As shown in FIG. 3, the tension wire 22 is pulled to its desiredtension, with the flexible tube 20 resting against a wall of the cavity.

The flexible tube 20 can be inflatable with a fluid such as air. Theinflatable tube 20 can have an inflation valve 26 (illustrated in FIG.4) accessible for inflation when the catheter 12 is positioned in thebody cavity. The inflatable tube 20 can be inflated via a small tubewhich is embedded within the wall 18 of the narrow profile balloon 10and through the catheter 20 to an inflation device exterior the catheter12 and the body. Alternatively, the inflatable tube 20 can be inflatedprior to insertion of the catheter 12 with the wall 18 fully extended asshown in FIG. 1.

FIG. 5 illustrates an example of an aortic occlusion device 100.Although the aortic occlusion device illustrates the use of three narrowprofile balloons 10, one or more narrow profile balloons 10 can be usedwith a catheter 12. Alternatively, one or more narrow profile balloons10 can be used in combination with conventional balloons. For example, acatheter 12 can include a plurality of balloons, with an intermediateballoon being the narrow profile balloon 10 configured on the catheter12 to allow for placement of the flexible tube 20 between two arterialports. Alternatively, the catheter 12 can include all narrow profileballoons 10.

The aortic occlusion device 100 shown in FIG. 5 has three narrow profileballoons B1, B2, B3. One example of use of such an aortic occlusiondevice 100 is for insertion into a femoral artery 102 of a body into thedescending aorta 104. FIG. 6 depicts the femoral artery 102 in relationto the heart and pelvic area for illustrative purposes only. In theaortic occlusion device illustrated in FIG. 5, the distal narrow profileballoon B1 is spaced from the intermediate narrow profile balloon B2such that the distal narrow profile balloon B1 is located proximate adiaphragm 105 in an adult body. A third narrow profile balloon B3 isspaced from the intermediate narrow profile balloon B2 opposite thedistal narrow profile balloon B1 such that the intermediate narrowprofile balloon B2 and the third narrow profile balloon B3 span renalports 106 in the adult body.

Each of narrow profile balloons B1, B2, B3 is selectively inflated, ifthe flexible tube is inflatable, and tensioned with the respectivetension wire(s) 22, when the catheter 12 is positioned within the cavityof the body. As a non-limiting example, when the catheter 12 is a closedcatheter and is positioned in the aorta 104 through the femoral artery102, the distal narrow profile balloon B1 can be tensioned to stop bloodflow below the diaphragm. All three narrow profile balloons B1, B2, B3can be tensioned as illustrated in FIG. 7A, so that when blood is readyto be introduced below the diaphragm, tension on the narrow profileballoons B1, B2, B3 can be slowly and sequentially released to slowlyintroduce blood flow and avoid a sudden drop in blood pressure, which istypical with conventional devices. As illustrated in FIG. 7B, theintermediate narrow profile balloon B2 and the third narrow profileballoon B3 can be tensioned, with the distal narrow profile balloon B1in its released state, to allow blood flow to celiac ports 107 butprevent blood flow in the descending aorta 104 beyond the celiac ports107. The third narrow profile balloon B3 can be tensioned, with theintermediate and distal narrow profile balloons B1, B2 in their releasedstate, to allow blood to flow to the renal ports 106 but prevent bloodto flow in the descending aorta 104 beyond the renal ports 106.

The aortic occlusion device 100 can further comprise an external control110, illustrated in FIG. 8, engaged with the at least one tension wire22 of each of the narrow profile balloons (for example, B1, B2, B3)included in the device 100 and configured to selectively pull or releaseeach of the at least one tension wire 22 to move the flexible tube 20 ofeach narrow profile balloon toward a wall of the aorta 104. As anon-limiting example, the external control 110 can have sliders 112,each slider 112 connected to a tension wire(s) 22 of a narrow profileballoon. The sliders 112 can be individually moved to any position alonga respective track 114 to thereby move the narrow profile balloon to orfrom a closed, partially open or open position. The sliders 112 areconfigured to lock in place after positioned to the desired point alongthe respective track 114, such as by pushing the slider 112 in orpulling the slider 112 outward to a locking position. The externalcontrol 110 can also be engaged with the inflation valve 26 associatedwith a respective narrow profile balloon and configured to selectivelyexpand the inflatable tube 20 of the narrow profile balloon. As anon-limiting example, the external control 110 can include a switch 116that activates a valve that is connected to a fluid supply, such as air,through a fluid supply conduit 117. Each narrow profile balloon of anaortic occlusion device will be associated with a switch 116 toselectively inflate and deflate as required.

The sliders 112 and/or the tension wires 22 can be tension sensitive toavoid overexpansion of the narrow profile balloons, causing damage to awall of the cavity in which the narrow profile balloon is positioned.The external control 110 can be further configured to monitor tension oneach tension wire 22 and to stop further exertion on any tension wire 22when that tension wire 22 reaches a threshold tension. The externalcontrol 110 can be further configured to monitor the pressure betweenthe flexible tube of each narrow profile balloon and a wall of the aorta104 as a respective tension wire 22 is pulled. An internal mechanicalmechanism can be included that prevents further movement of the slider112 when the threshold is met, and/or can reduce inflation of theflexible tube 20 by releasing some fluid through the valve when thethreshold is met. The external control 110 can also or alternativelycomprise a digital display 118 of one or both of tension on each tensionwire 22 and pressure between the flexible tube and the wall of the aorta104. The digital display 118 can be incorporated into the externalcontrol 110 or can be a separate display in communication with theexternal control 110.

FIG. 9 illustrates a method of using an aortic occlusion devicedisclosed herein. Using an aortic occlusion device having a plurality ofballoons, with at least one of the plurality of balloons being thenarrow profile balloon 10 disclosed herein, one method comprises firstinserting the catheter 12 into a body cavity or vessel within a human oranimal body in step S10. The catheter 12 is then positioned such that adistal balloon of the plurality of balloons is located in a desiredlocation within the body cavity or the vessel in step S12. Tension isthen placed the tension wire(s) 22 attached to the movable end 16 of thenarrow profile balloon 10 to move the movable end 16 towards theanchored end 14 in step S14, thereby moving the flexible tube 20 tocontact a wall of the body cavity or vessel, blocking blood flow belowthe flexible tube 20.

The method can further include inflating the flexible tube prior toplacing tension on the tension wire(s) 22 in step S14. The method canfurther include gradually releasing the tension on the tension wire(s)22 attached to the movable end 16 of the narrow profile balloon 10,thereby gradually reinstating blood flow past the narrow profile balloon10, preventing a rapid drop in afterload and blood pressure.

Also disclosed herein are selective aortic balloon occlusion devices(SABOT). The selective aortic balloon occlusion devices are used forSelective Aortic Balloon Occlusion in Trauma (SABOT) and allow forocclusion of flow through the aorta to control hemorrhage in trauma. TheSABOT may also play an important role in the medical resuscitations byadjusting afterload and relative intravascular volume, as furtherdescribed herein.

One embodiment of a SABOT 200 is illustrated in FIG. 10 and comprises acatheter 212 comprising an open distal end 214 and a plurality ofadjustable port regions P1, P2, P3 with inflatable balloons B1, B2, B3between adjacent adjustable port regions P1, P2, P3 and the open distalend 214 as illustrated. Each adjustable port region P1, P2, P3 isconfigured to move between a closed position and an open position toselectively allow fluid flow to enter the catheter 212 through the opendistal end 214 and to exit the catheter 212 through one or more of theplurality of adjustable port regions P1, P2, P3 depending on aninflation pattern of the inflatable balloons B1, B2, B3. Although threeinflatable balloons B1, B2, B3 and three adjustable ports P1, P2, P3 areillustrated, the number is not meant to be limiting. The adjustableports P1, P2, P3 allow flow of blood out of the catheter 212 toselectively perfuse different regions of the body.

Although the balloons B illustrated in the figures are shown as a narrowprofile balloon disclosed herein, the balloons B can be conventionalballoons or a combination of conventional balloons and narrow profileballoons. As a non-limiting example, a conventional balloon may be usedas the most distal balloon B1 for stability when used in the aorta, withthe other balloons BN being narrow profile balloons.

The open distal end 214 can have a single opening or can have multipleapertures forming the opening as illustrated. The open distal end 214can be configured to always be open, or can be an adjustable openingsimilar to the adjustable port regions PN as disclosed herein. Thecatheter 212 is at least partially hollow from the open distal end 214to a location downstream of the most downstream adjustable port regionto allow fluid such as blood to flow through the catheter until thelocation downstream of the most downstream adjustable port region.

Each adjustable port region has an inner perforated element, an outerperforated element, and a tension spring. The tension spring ispositioned such that the ports are in a closed position by default. Asillustrated in FIG. 11, each adjustable port region PN of a SABOT 200comprises an outer catheter tube 216 having at least one outer aperture218 there through and an inner tube 220 sized to movably fit within theouter catheter tube 216 and having at least one inner aperture 222 therethrough. A biasing member 224 is attached to the inner tube 220, biasingthe inner tube 220 so that the inner aperture(s) 222 and the outeraperture(s) 218 are fully offset in the closed position as illustratedin FIG. 12A. The biasing member 224 is configured to move the inner tube220 to gradually overlap the inner aperture(s) 222 and the outeraperture(s) 218 through intermediate positions shown in FIG. 12B andthrough to the open position, illustrated in FIG. 12C, where the inneraperture(s) 222 and the outer aperture(s) 218 are fully aligned.

The outer aperture 218 and the inner aperture 222 can be configured as asingle aperture on each of the outer catheter tube 216 and the innertube respectively or can each be a plurality of apertures 218, 222spaced around a circumference of the outer catheter tube 216 and theinner tube 220, respectively, in one or a plurality of rows, asillustrated in the figures. Alternatively, the plurality of apertures218, 222 can be spaced longitudinally along the outer catheter tube 216and the inner tube 220, respectively. These configurations are providedby means of example and are not meant to be limiting.

The SABOT can further include an external controller 230 as illustratedin FIG. 13. The external controller 230 can be in separate communicationwith each adjustable port region PN and each inflatable balloon BN andconfigured to independently inflate and deflate each balloon BN andindependently move each adjustable port region PN between the closedposition and the open position.

As a non-limiting example, the external control 230 can have sliders232, each slider 232 connected to biasing member 224 of an adjustableport region PN through a connection member 233 such as a wire. Thesliders 232 can be individually moved to any position along a respectivetrack 234 to thereby move the biasing member 224 to thereby move theinner tube 220 along a length of the catheter 212 to move the respectiveadjustable port region among closed, partially open and open positions.The sliders 232 can be configured to lock in place after beingpositioned to the desired point along the respective track 234, such asby pushing the slider 232 in or pulling the slider 232 outward to alocking position. The external control 230 can also be engaged with aninflation valve associated with a respective inflatable balloon BN andconfigured to selectively expand the inflatable balloon BN. As anon-limiting example, the external control 230 can include a valve 236connected through a fluid supply conduit 237 between a respectiveinflation valve of an inflatable balloon BN and a fluid supply, such asair.

If narrow profile balloons 10 are used as disclosed herein, the externalcontrol 230 can also engage the at least one tension wire 22 of each ofthe narrow profile balloons 10 included in the SABOT 200 and configuredto selectively pull or release each of the at least one tension wire 22to move the flexible tube 20 of each narrow profile balloon 10 toward awall of the body cavity or vessel. As a non-limiting example, theexternal control 230 can have sliders 238, each slider 238 connected toa tension wire(s) 22 of a narrow profile balloon 10. The sliders 238 canbe individually moved to any position along a respective track 240 tothereby move the narrow profile balloon 10 among closed, partially openor open positions. The sliders 238 are configured to lock in place afterbeing positioned to the desired point along the respective track 240,such as by pushing the slider 238 in or pulling the slider 238 outwardto a locking position. By adjusting the tension on each biasing member224 with a respective slider 232, the ports can be opened to varyingdegrees, which allows for adjustable flow at any level, independent ofother levels.

The sliders 238 and/or the tension wires 22 can be tension sensitive toavoid overexpansion of the narrow profile balloons 10, causing damage toa wall of the cavity in which the narrow profile balloon 10 ispositioned. The external control 230 can be further configured tomonitor tension on each tension wire 22 and to stop further exertion onany tension wire 22 when that tension wire 22 reaches a thresholdtension. The external control 230 can be further configured to monitorthe pressure between the flexible tube of each narrow profile balloonand a wall of the body cavity or vessel as a respective tension wire 22is pulled. An internal mechanical mechanism can be included thatprevents further movement of the slider 238 when the threshold is met,and/or can reduce inflation of the flexible tube 20 by releasing somefluid through the valve 237 when the threshold is met. The externalcontrol 230 can also or alternatively comprise a digital display 118 ofone or each of tension on each tension wire 22, pressure between theflexible tube 20 and the wall of the cavity or vessel, and an open orclosed position of each adjustable port region PN. The digital display118 can be incorporated into the external control 230 or can be aseparate display in communication with the external control 230 by ahard wired means or a wireless means.

Another embodiment of a SABOT 250 is illustrated in FIG. 14 andcomprises the catheter 212 comprising the open distal end 214 configuredto be inserted into a body cavity or vessel and a first adjustable portregion P1 with a first balloon B1 downstream of the open distal end 214and upstream of the first adjustable port region P1. A second balloon B2is positioned downstream of the first adjustable port region P1. Asecond adjustable port region P2 is downstream of the second balloon B2.The first adjustable port region P1 and the second adjustable portregion P2 are each configured to selectively move between an openposition and a closed position, wherein the open position allows flowinto the open distal end 214 through the catheter 212 and exitingthrough one or both of the first adjustable port region P1 and thesecond adjustable port region P2 when in the open position, and theclosed position prevents flow through one or both of the firstadjustable port region P1 and the second adjustable port region P2 whenin the closed position.

An example of a method of using the SABOT of FIG. 14 is illustrated inFIGS. 15 and 16. The method comprises inserting the catheter 212 intothe cavity or vessel to a desired position in step S20. Once positioned,both of the first balloon Bland the second balloon B2 are selectivelyinflated in step S22. The first adjustable port region P1 is moved tothe closed position in step S24. It is noted that the catheter 212 canbe inserted with all adjustable ports in the closed positions, so movingthe first adjustable port region P1 includes maintaining the firstadjustable port region P1 in the closed position. The second adjustableport region P2 is moved to the open position in step S26, therebyisolating the cavity or vessel between the first balloon B1 and thesecond balloon B2 while allowing fluid to flow to the cavity or vesseldownstream of the second balloon B2.

FIG. 16 illustrates a specific example of the SABOT of FIG. 14. In FIG.16, the first balloon B1 and t second balloon B2 are configured to bespaced on the catheter 212 such that, when the catheter 212 is insertedin a descending aorta 104 through a femoral artery 102 of an adulthuman, the first balloon B1 would be positioned proximate a diaphragm105 and the second balloon B2 would be positioned between celiac ports107 and renal ports 106. The catheter 212 is inserted into the femoralartery 102 and into the descending aorta 104, positioning the firstballoon B1 proximate the diaphragm 105, thus placing the second balloonB2 between the celiac ports 107 and the renal ports 106. Both the firstballoon B1 and the second balloon B2 are selectively inflated. The firstadjustable port region P1 is in the closed position and the secondadjustable port region P2 is moved to the open position, therebyisolating the celiac ports 107 while allowing fluid to flow through thecatheter 212 and out of the second adjustable port region P2 to therenal ports 106 and ports downstream of the renal ports 106.

Methods of using the embodiment of the SABOT 200 in FIG. 10 are alsodisclosed. One such method illustrated in FIG. 17 comprises insertingthe catheter 212 into the cavity or vessel to a desired position in stepS30, selectively inflating one or more of the first balloon B1, thesecond balloon B2 and the third balloon B3 in step S32 and selectivelyadjusting each of the first, second and third adjustable port regionsP!, P2, P3 between the open position and the closed position in stepS34. Selectivity is based on isolating a portion of the cavity or vesselor testing a portion of the cavity or vessel.

The second balloon B2 and the third balloon B3 can be configured on thecatheter 212 such that when the catheter 212 is inserted in a descendingaorta 104 through a femoral artery 102 of an adult human and the firstballoon B1 is positioned proximate a diaphragm 105, the second balloonB2 is positioned between celiac ports 107 and renal ports 106 and thethird balloon B3 is positioned between renal ports 106 and pelvic ports102. This is illustrated in FIG. 18. Using the SABOT configured in thisway, methods of use can include, but are not limited to, the followingexamples.

Each of the first balloon B1, the second balloon B2 and the thirdballoon B3 are inflated. The first adjustable port region P1 is placedin the open position while keeping ports in the second adjustable portregion P2 and the third adjustable port region P3 closed, therebyallowing fluid flow through the catheter 212 to only the celiac ports107 through the first adjustable port region P1 to test for injury tothe liver and spleen.

At least the first balloon B1 and the second balloon B2 are inflated.The first adjustable port region P1 is in the closed position whileopening ports in the second adjustable port region P2 and the thirdadjustable port region P3, thereby isolating the celiac ports 107 fromfluid flow but allowing fluid flow through the catheter 212 to the renalports 106 through the second adjustable port region P2 and pelvic ports102 through the third adjustable port region P3.

Each of the first balloon B1, the second balloon B2 and the thirdballoon B3 are inflated. The first adjustable port region P1 and thesecond adjustable port region P2 are opened while keeping ports in thethird adjustable port region P3 closed, thereby allowing fluid flowthrough the catheter 212 to only the renal ports 106 through the secondadjustable port region P2 to test for injury to the kidneys.

At least the second balloon B2 and the third balloon B3 are inflated.The second adjustable port region P2 is closed while opening ports inthe first adjustable port region P1 and the third adjustable port regionP3, thereby isolating the renal ports 106 from fluid flow but allowingfluid flow through the catheter 212 to the celiac ports 107 through thefirst adjustable port region P1 and pelvic ports 102 through the thirdadjustable port region P3.

Each of the first balloon B1, the second balloon B2 and the thirdballoon B3 are inflated. The third adjustable port region P3 is openedwhile keeping ports in the first adjustable port region P1 and thesecond adjustable port region P2 closed, thereby allowing fluid flowthrough the catheter 212 to only the pelvic ports 102 through the thirdadjustable port region P3 to test for injury to the pelvic area.

At least the third balloon is inflated. The third adjustable port regionP3 is closed while keeping ports in the first adjustable port region P1and the second adjustable port region P2 open, thereby isolating thepelvic ports 102 from fluid flow but allowing fluid flow through thecatheter 212 to the renal ports 106 through the second adjustable portregion P2 and celiac ports 107 through the first adjustable port regionP1.

The methods of use and treatment and testing are summarized in Table 1below. The examples in the table are not meant to limit the methods,treatment or testing for which the SABOTs disclosed herein can be used.

TABLE 1 Condition Inflated Balloons Open Ports Closed Ports HypotensionB1, B2, B3 P1, P2, P3 Test injury B1, B2, B3 P1 P2, P3 liver/spleen Noliver injury/test B2, B3 P1, P2 P3 Kidney Liver injury/test B1, B2, B3P2 P1, P3 kidney Isolated Kidney Injury B2, B3 P1, P3 P2 Liver andkidney B1, B2, B3 P3 P1, P2 injury/test pelvis Isolated Pelvis Injury B3P1, P2 P3 BP stable None P1, P2, P3

The distal end of the catheter can be open with inflow perforations toallow blood flow into catheter at all times. The proximal end of thecatheter is closed and doesn't allow flow inside the catheter beyond thepelvic ports. The catheter is placed via the femoral artery and can beadvanced under ultrasound guidance when using an echogenic (embeddedwith metallic material) distal tip of the catheter as a guide. Once inplace, the balloons are inflated and the balloon deployment frames areexpanded if the narrow profile balloons are used. Ultrasound guidancecan be provided with the use of echogenic material on the frames of thenarrow profile balloons. The order of balloon inflation and expansioncan begin with balloon B1, then B2 followed by B3. Ports or perforationsin the catheter can be opened and closed partially or completely foradjustable flow and afterload at each section independently. Byinflating all balloons and closing all adjustable port cathetersections, flow is maintained to structures above the diaphragm (heart,brain, etc.). After placement confirmation and return of blood pressure,or after active serious bleeding has been excluded or corrected, portsshould be opened and balloons deflated and collapsed in sequence.

With the SABOT properly placed, blood flow can be occluded with balloonsand selectively opened with ports to perfuse: completely just below thediaphragm for hypovolemic shock without a known bleeding source; belowthe diaphragm, bypass to the liver and spleen, then adjustable flow tothe renal arteries and below; and below the renals, with continuous,adjustable flow to the iliac arteries and below. With the use of balloonexpansion control, sliders are tension sensitive to avoid overexpansionand vascular damage; and sliders can lock into place after adjustment.With the use of the biasing element adjustment, each area separately canbe placed in closed, partial open, or complete open positions; sliderscan lock into place after adjustment, and the spring loaded ports allowfor gradual opening, thereby preventing a rapid drop in afterload andblood pressure. Any combination of the above can be used depending onthe site of injury.

Provided below is an example of a sequence of testing that can be donewith the SABOTs disclosed herein, with or without the narrow profileballoons.

Sequence: Test for Liver/Spleen Injury

-   -   After stabilization, P1 is gradually opened, allowing flow to        the liver, spleen and stomach.    -   If the patient becomes unstable, the ports may be reclosed and        the patient should be considered to have a liver or splenic        injury.    -   If blood pressure remains stable, B1 is deflated and collapsed.        Sequence: Liver/Spleen Injury Found, so Test for Renal Injury    -   Next, with B1 inflated and P1 closed due to assumed liver spleen        injury, P2 to the renal ports should be gradually opened.    -   If blood pressure becomes unstable, reclose ports and consider a        renal injury.    -   If patient remains stable after opening the renal ports P2, keep        them open to selectively perfuse kidneys.        Sequence: No Liver/Spleen or Renal Injury    -   After exclusion of Liver/Spleen and Renal injury, B1 and B2        should be deflated; P1 (celiac) and P2 (renal) remain open.        Sequence: Pelvic/Lower Extremity Injury    -   With successful reperfusion of liver/spleen and renals, the        pelvic ports (P3) should be gradually opened.    -   If blood pressure is unstable after gradually attempting        pelvic/lower extremity reperfusion, the ports should be reclosed        and a pelvic/lower extremity bleeding source should be assumed.    -   Do not deflate B3 in this circumstance.        Isolated Renal Injury    -   If BP stable with Liver/Spleen reperfusion, but unstable with        renal reperfusion, and stable with pelvic reperfusion, keep B2        and B3 expanded and inflated and P1 (celiac) and P3 (pelvic)        open.

Provided below are examples of other uses of the SABOTs disclosedherein, with or without the narrow profile balloons.

1. Traumatic Shock:

-   -   a. Multi-level balloons, blood flow, Ports between the levels of        the balloons to selectively and independently open areas of        perfusion    -   b. Allows to isolate hemorrhaging areas, perfuse areas distant        to hemorrhage so as to decrease amount of lactic acid build-up        and permanent ischemic injury.

2. Post-Arrest Cardiogenic Shock:

-   -   c. Stunned myocardium after cardiopulmonary arrest and return of        spontaneous circulation (ROSC) would not have to work as hard if        internal cross-clamping of aorta occurred with this device. This        device would allow gradual level reperfusion of the organs,        gradually increasing the amount of work the myocardium does as        it is recovering.

3. Septic Hypotensive Shock

-   -   d. In septic shock, the body preferentially perfuses the vital        organs (brain, heart, kidneys) by shunting away from less        essential (mesenteric structures, periphery). In the case of        massive vasodilatation due to endovascular toxin release, this        device would assist in closing off or partially perfusing        certain areas—an assistive shunt of sorts.

4. Anaphylactic Hypotensive Shock

-   -   e. Massive vasodilation occurs. Blood pressure drop could be        aided by shunting blood to vital organs (brain, heart, kidneys)        and effectively shunting blood away from less vital organs for a        brief period of time. Then you can use the device to gradual        open and reperfuse other arterial beds as body is responding to        medication.

Other potential markets for the SABOTs disclosed herein include, but arenot limited to neurogenic shock, resuscitation with unclear etiology(post-arrest), emergent bypass of leaking AAA, and pre-operativeplacement for immediate control of intraoperative bleeding.

Table 2 below is a brief comparison of the SABOTs disclosed herein withthe conventional devices.

TABLE 2 Conventional Devices SABOT All or nothing approach Segmentalperfusion possible Poor control over reperfusion Sequential and partialreperfusion Can't perfuse kidneys, bowel Able to perfuse specificvascular beds in or lower extremities if other isolation (kidneys,liver/spleen, lower intrabdominal bleeding extremities) exists Largeballoons Narrow-profile balloon allows for precise placement Crudeestimate of pressure Controlled pressure to prevent vascular applied toaortic walls damage

The SABOT allows bypass of injured organs selectively via the portedcatheter. With conventional devices, no bypass perfusion is possible. Ifinjury is at the level of the liver or spleen (celiac level), the supraceliac balloon must remain inflated preventing perfusion to the entirebody below the diaphragm.

The SABOT has port size adjustment, which provides for a more preciseand gradual reperfusion thereby eliminating a sudden drop in afterloadand thus blood pressure with recurrent shock. This also decreases therate of inflammatory mediator release allowing for the gradualadjustment of the circulatory system and involved organs to theonslaught of shock-inducing agents. With the conventional devices,reperfusion is accomplished via deflation of balloons above the site ofinjury which is inherently inconsistent and offers poor control.

The narrow profile balloons disclosed herein have an expansion frameupon which the balloon is mounted that can be attached to a slide andthe tension applied for expansion as well as the pressure within theballoon can be quantitated in order to prevent vascular injury.Conventional devices have no expansion frame.

The narrow profile balloon allows more precise placement and thereforecan be positioned in the highly important narrow space (for example,approximately 2 cm.) between the celiac and renal arteries, thusallowing bypass to the kidney's while preventing flow to the liver,spleen, intestine, pelvis and lower extremities. Conventional (wide)profile balloons make precise positioning impossible. The metal supportsin the expansion frame can be used for ultrasonographic placement andverification. Metal impregnation (or other sound reflective material) inthe catheter tip allows easier ultrasonographic identification of thecatheter tip.

The SABOT is designed to be used with a reusable external controller forprecise balloon and port control. No such device exists for use with aconventional device.

The SABOT is designed to be placed in the femoral artery via currentlyaccepted protocols which involves less risk, larger access and lesscumbersome than a carotid artery approach. Conventional devices aredesigned to be placed via the carotid artery.

The above-described aspects, examples, and implementations have beendescribed in order to allow easy understanding of the disclosure are notlimiting. On the contrary, the disclosure covers various modificationsand equivalent arrangements included within the scope of the appendedclaims, which scope is to be accorded the broadest interpretation so asto encompass all such modifications and equivalent structure as ispermitted under the law.

What is claimed is:
 1. A selective aortic balloon occlusion devicecomprising: a catheter comprising: a distal end configured to beinserted into a body cavity or vessel, the distal end having at leastone opening; a first balloon downstream of the distal end; a firstadjustable port region downstream of the first balloon; a second balloondownstream of the first adjustable port region; and a second adjustableport region downstream of the second balloon, the first adjustable portregion and the second adjustable port region each configured toselectively individually move between an open position and a closedposition, wherein: the open position allows flow into the distal endthrough the catheter and exiting through an opened adjustable portregion; and the closed position prevents flow through a closedadjustable port region, wherein each of the first adjustable port regionand the second adjustable port region comprises: an outer catheter tubehaving at least one outer aperture there through; an inner tube sized tomovably fit within the outer catheter tube and having at least one inneraperture there through; and a biasing member attached to the inner tube,biasing the inner tube so that the at least one inner aperture and theat least one outer aperture are offset in the closed position, thebiasing member configured to move the inner tube to gradually overlapthe at least one inner aperture and the at least one outer aperturethrough intermediate positions to the open position, where the at leastone inner aperture and the at least one outer aperture are fullyaligned.
 2. The selective aortic balloon occlusions device of claim 1,wherein the biasing member is a spring.
 3. The selective aortic balloonocclusion device of claim 1, wherein the at least one outer aperture andthe at least one inner aperture are each a plurality of apertures spacedaround a circumference of the outer catheter tube and the inner tuberespectively.
 4. The selective aortic balloon occlusion device of claim3, wherein the plurality of apertures spaced around the circumference ofthe outer catheter tube and the inner tube respectively are eachconfigured to be in a plurality of rows.
 5. The selective aortic balloonocclusion device of claim 1, wherein each of the at least one outeraperture and the at least one inner aperture are a plurality ofapertures spaced longitudinally along the outer catheter tube and theinner tube, respectively.
 6. The selective aortic balloon occlusiondevice of claim 1 further comprising: an external controller in separatecommunication with the first adjustable port region, the secondadjustable port region, the first balloon and the second balloon andconfigured to: independently inflate and deflate each of the firstballoon and the second balloon; and independently move the firstadjustable port region between the closed position and the open positionand the second adjustable port region between the closed position andthe open position.
 7. The selective aortic balloon occlusion device ofclaim 1, wherein the first balloon and the second balloon are configuredto be spaced on the catheter such that, when the catheter is inserted ina descending aorta through a femoral artery of an adult human, the firstballoon is positioned proximate a diaphragm and the second balloon ispositioned between celiac ports and renal ports.
 8. A method of usingthe selective aortic balloon occlusion device of claim 7 comprising:inserting the catheter into the femoral artery and into the descendingaorta, positioning the first balloon proximate the diaphragm, thusplacing the second balloon between the celiac ports and the renal ports;selectively inflating both the first balloon and the second balloon;maintaining or moving the first adjustable port region to the closedposition; and moving the second adjustable port region to the openposition, thereby isolating the celiac ports while allowing fluid toflow through the catheter and out of the second adjustable port regionto the renal ports and ports downstream of the renal ports.
 9. A methodof using the selective aortic balloon occlusion device of claim 1comprising: inserting the catheter into the cavity or vessel to adesired position; selectively inflating both the first balloon and thesecond balloon; maintaining or moving the first adjustable port regionto the closed position; and moving the second adjustable port region tothe open position, thereby isolating the cavity or vessel between thefirst balloon and the second balloon while allowing fluid to flow to thecavity or vessel downstream of the second balloon.
 10. The selectiveaortic balloon occlusion device of claim 1 further comprising: a thirdballoon downstream of the second adjustable port region; and a thirdadjustable port region downstream of the third balloon, wherein thethird adjustable port region is configured to move between an openposition and a closed position.
 11. The selective aortic balloonocclusion device of claim 10, further comprising: an external controllerin independent communication with each of the first adjustable portregion, the second adjustable port region, the third adjustable port,the first balloon, the second balloon and the third balloon andconfigured to: independently inflate and deflate each of the firstballoon, the second balloon and the third balloon; and independentlymove each of the first adjustable port region, the second adjustableport region, and the third adjustable port region between a respectiveclosed position and open position.
 12. The selective aortic balloonocclusion device of claim 10, wherein the second balloon and the thirdballoon are configured on the catheter such that when the catheter isinserted in a descending aorta through a femoral artery of an adulthuman and the first balloon is positioned proximate a diaphragm, thesecond balloon is positioned between celiac ports and renal ports andthe third balloon is positioned between renal ports and pelvic ports.13. A method of using the selective aortic balloon occlusion device ofclaim 10 comprising: inserting the catheter into the cavity or vessel toa desired position; selectively inflating one or more of the firstballoon, the second balloon and the third balloon; and selectivelyadjusting one or more of the first, second and third adjustable portregions between the open position and the closed position.
 14. Themethod of claim 13, wherein the second balloon and the third balloon areconfigured on the catheter such that when the catheter is inserted in adescending aorta through a femoral artery of an adult human and thefirst balloon is positioned proximate a diaphragm, the second balloon ispositioned between celiac ports and renal ports and the third balloon ispositioned between renal ports and pelvic ports, the method comprising:inflating each of the first balloon, the second balloon and the thirdballoon; and opening ports in the first adjustable port region whilekeeping ports in the second adjustable port region and the thirdadjustable port region closed, thereby allowing fluid flow through thecatheter to only the celiac ports through the first adjustable portregion to test for injury to the liver and spleen.
 15. The method ofclaim 13, wherein the second balloon and the third balloon areconfigured on the catheter such that when the catheter is inserted in adescending aorta through a femoral artery of an adult human and thefirst balloon is positioned proximate a diaphragm, the second balloon ispositioned between celiac ports and renal ports and the third balloon ispositioned between renal ports and pelvic ports, the method comprising:inflating at least the first balloon and the second balloon; and closingports in the first adjustable port region while keeping ports in thesecond adjustable port region and the third adjustable port region open,thereby isolating the celiac ports from fluid flow but allowing fluidflow through the catheter to the renal ports through the secondadjustable port region and pelvic ports through the third adjustableport region.
 16. The method of claim 13, wherein the second balloon andthe third balloon are configured on the catheter such that when thecatheter is inserted in a descending aorta through a femoral artery ofan adult human and the first balloon is positioned proximate adiaphragm, the second balloon is positioned between celiac ports andrenal ports and the third balloon is positioned between renal ports andpelvic ports, the method comprising: inflating each of the firstballoon, the second balloon and the third balloon; and opening ports inthe first adjustable port region and the second adjustable port regionwhile keeping ports in the third adjustable port region closed, therebyallowing fluid flow through the catheter to only the renal ports throughthe second adjustable port region to test for injury to the kidneys. 17.The method of claim 13, wherein the second balloon and the third balloonare configured on the catheter such that when the catheter is insertedin a descending aorta through a femoral artery of an adult human and thefirst balloon is positioned proximate a diaphragm, the second balloon ispositioned between celiac ports and renal ports and the third balloon ispositioned between renal ports and pelvic ports, the method comprising:inflating at least the second balloon and the third balloon; and closingports in the second adjustable port region while keeping ports in thefirst adjustable port region and the third adjustable port region open,thereby isolating the renal ports from fluid flow but allowing fluidflow through the catheter to the celiac ports through the firstadjustable port region and pelvic ports through the third adjustableport region.
 18. The method of claim 13, wherein the second balloon andthe third balloon are configured on the catheter such that when thecatheter is inserted in a descending aorta through a femoral artery ofan adult human and the first balloon is positioned proximate adiaphragm, the second balloon is positioned between celiac ports andrenal ports and the third balloon is positioned between renal ports andpelvic ports, the method comprising: inflating each of the firstballoon, the second balloon and the third balloon; and opening ports inthe third adjustable port region while keeping ports in the firstadjustable port region and the second adjustable port region closed,thereby allowing fluid flow through the catheter to only the pelvicports through the third adjustable port region to test for injury to thepelvic area.
 19. The method of claim 13, wherein the second balloon andthe third balloon are configured on the catheter such that when thecatheter is inserted in a descending aorta through a femoral artery ofan adult human and the first balloon is positioned proximate adiaphragm, the second balloon is positioned between celiac ports andrenal ports and the third balloon is positioned between renal ports andpelvic ports, the method comprising: inflating at least the thirdballoon; and closing ports in the third adjustable port region whilekeeping ports in the first adjustable port region and the secondadjustable port region open, thereby isolating the pelvic ports fromfluid flow but allowing fluid flow through the catheter to the renalports through the second adjustable port region and celiac ports throughthe first adjustable port region.